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The purpose of this first-in-human study of the formulation ABY-035/AFO2 is to investigate the safety, tolerability and efficacy after multiple doses in sequential escalating dose cohorts in psoriasis subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1:75 mg ABY-035/AFO2 | Experimental | Cohort 1: 75 mg ABY-035/AFO2, once daily for 14 days |
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| Cohort 2: 150 mg ABY-035/AFO2 | Experimental | Cohort 2: 150 mg ABY-035/AFO2 once daily for up to 28 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABY-035/AFO2 | Biological | Analyze the safety, tolerability, PK, and efficacy of ABY-035/AFO2 that 25 subjects will receive for treatment of their active plaque psoriasis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with treatment-related Adverse Events as assessed by the principles of Common Terminology Criteria for Adverse Events (CTCAE) | 5 male and female psoriasis subjects will be enrolled to obtain who complete treatment or drop out due to adverse events for Cohorts 1 and 2 | 28 Days |
| Number of subjects with treatment-related Adverse Events as assessed by the principles of Common Terminology Criteria for Adverse Events (CTCAE) | 20 male and female psoriasis subjects will be enrolled to obtain who complete treatment or drop out due to adverse events for Cohort 3 | 42 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects´ level of anti-drug antibodies (ADAs) in the blood | To assess the immunogenicity of ABY-035 after multiple doses of ABY 035/AFO2 in psoriasis subjects | 14 Days dosing period for Cohort 1, 28 Days dosing period for Cohort 3 and 14 Days follow-up period for all Cohorts |
| If subjects have assessable pharmacokinetics (PK) of ABY-035 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tooraj Raoof, MD | Encino Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raoof, Joseph | Encino | California | 16133 | United States |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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An exploratory, clinical study with 2 open-dose cohorts is designed to analyze the safety, tolerability, PK, and efficacy of ABY-035/AFO2 in the treatment of subjects with active plaque psoriasis.
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To investigate the peak plasma concentration (Cmax ) of ABY-035 after multiple doses of ABY-035/AFO2 in psoriasis subjects |
| 14 Days dosing period for Cohort 1, 28 Days dosing period for Cohort 3 and 14 Days follow-up period for all Cohorts |
| If subjects have assessable pharmacokinetics (PK) of ABY-035 | To investigate the Area under the curve (AUC) versus time curve of ABY-035/AFO2 in psoriasis subjects | 14 Days dosing period for Cohort 1, 28 Days dosing period for Cohort 3 and 14 Days follow-up period for all Cohorts |
| Efficacy assessment: The change of the subjects´ scaling of a selected target plaque from baseline to the last visit | The results will be summarized as number and percent by visit. Tables from baseline will be prepared for all timepoints | 14 Days dosing period for Cohort 1, 28 Days dosing period for Cohort 3 and 14 Days follow-up period for all Cohorts |
| Efficacy assessment: The change of the subjects´erythema of a selected target plaque from baseline to the last visit | The results will be summarized as number and percent by visit. Tables from baseline will be prepared for all timepoints | 14 Days dosing period for Cohort 1, 28 Days dosing period for Cohort 3 and 14 Days follow-up period for all Cohorts |
| Efficacy assessment: The change of the subjects´ thickness of a selected target plaque from baseline to the last visit | The results will be summarized as number and percent by visit. Tables from baseline will be prepared for all timepoints | 14 Days dosing period for Cohort 1, 28 Days dosing period for Cohort 3 and 14 Days follow-up period for all Cohorts |